Pharmaceutical particulars : מידע רוקחי

6.           PHARMACEUTICAL PARTICULARS

6.1          List of excipients
Anhydrous sodium carbonate


6.2          Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3          Shelf life
The expiry date of the product is indicated on the packaging materials.

After reconstitution:

Intravenous bolus injection administration
A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration of 50 mg/ml. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated for 3 hours at up to 25°C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately in-use storage times and conditions are the responsibility of the user.

The constituted solutions should not be frozen.
Intravenous infusion administration
A solution for infusion is prepared by dissolving the drug product in either 0.9% sodium chloride solution for infusion or 5% glucose (dextrose) solution for infusion to a final concentration of 1 to 20 mg/ml. Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 3 hours at up to 25°C or 24 hours under refrigerated conditions (2-8°C).

Constituted solutions of Meronem IV in 5% glucose (dextrose) solution should be used immediately.

The constituted solutions should not be frozen.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately in-use storage times and conditions are the responsibility of the user.

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6.4          Special precautions for storage
Do not store above 30°C.

Do not freeze the reconstituted solution.

For storage conditions after reconstitution of the medicinal product, see section 6.3.


6.5          Nature and contents of container
Type 1 glass vial with halobutilic rubber stopper and sealed with an aluminium cap) 
The medicinal product is supplied in pack sizes of 1 or 10 vials.

Not all pack sizes may be marketed.
6.6          Special precautions for disposal and other handling
Injection
Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection.

Infusion
For intravenous infusion meropenem vials may be directly constituted with 0.9% sodium chloride or 5% glucose solutions for infusion.

Each vial is for single use only.

Standard aseptic techniques should be used for solution preparation and administration.
The solution should be shaken before use.

Any unused product or waste material should be disposed of in accordance with local requirements.